DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Applicant failed to provide any response to the comments regarding priority found in the previous office action mailed, September 12, 2025. The comments are reiterated herein.
Applicant’s arguments, see amendment and remarks, filed January 12, 2026, with respect to objection to the title have been fully considered and are persuasive. The objection to the title has been withdrawn.
Applicant’s arguments, see amendment and remarks, filed January 12, 2026, with respect to objection to the abstract have been fully considered and are persuasive. The objection to the abstract has been withdrawn.
Rejection of claim 19 under 35 U.S.C. 112(b) and (d) is moot in view of cancellation of claim 19. The limitations of claim 19 have not been reiterated as a new claim.
Applicant's arguments filed January 12, 2026 have been fully considered, but they are not persuasive. A difference between new claims 21-38 and original claims 1-18 includes original claim 1 required the first K-wire to be inserted into the proximal phalanx, wherein the first aperture is located within the proximal phalanx, and the second K-wire is inserted into the middle phalanx, wherein the second aperture is located within the middle phalanx. The new claims have also been amended to remove method steps of “removing the first K-wire from the proximal phalanx” and “removing the second K-wire from the middle phalanx”. When comparing these altered claim limitations to Applicant’s originally filed specification, they appear to be directed to the first and second wires, which are inserted first, then second, into the proximal and middle phalanxes, respectively, so as to form respective firstly and secondly formed apertures. See specification objection below regarding antecedent basis in the specification for newly recited claim limitations of new claims 21-38. Thus, the abovementioned recitations of “first” and “second” wires and apertures are not related to an order of claimed method steps. Regardless of actual claim scope, Applicant argues that Applicant’s invention is distinct from the prior art to Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”) because Austin discloses a method of implanting including inserting the implant into the middle phalanx first, followed by insertion of the implant into the proximal phalanx. While, Applicant’s filed specification at paragraphs [0029]-[0030] discusses “the implant 100, 200 may first be delivered into the proximal phalanx to an appropriate depth… [0030] Next, the distal portion 104, 204 of the implant 100 … can be distracted distally to advance the distal portion of the implant into the middle phalanx….,” the above distinction between order of implanting ends of the implant are not found within Applicant’s filed independent claim. While the newly filed claims include references to “first and second” K-wires and “first and second” apertures, as discussed above, the claims do not positively require the method steps to be followed in a specific order. Moreover, while the claims require the method step of “manually compressing the distal portion of the cannulated implant within the middle phalanx,” Austin expressly teaches distal portion (104, 604) of the cannulated implant is manually compressed within the middle phalanx (e.g., see at least figures and paragraph [0065]). Thus, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a specific order in which the method steps are preformed) are not recited in the independent claim, as argued by Applicant. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Moreover, new dependent claim 23 does require the method to further comprise a specific ordering of method steps. In particular claim 23 recites, “advancing the first K-wire into the middle phalanx and across a metatarsophalangeal joint after inserting the proximal portion of the cannulated implant into the second aperture of the proximal phalanx.” However, this limitation is not found persuasive because selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). In the instant case, Applicant has failed to show how or why any new or unexpected results are formed by changing the order of the method steps. In Applicant’s invention, just like that of the prior art, each of the distal and proximal portions of the cannulated implant are compressed into their respective portions of bone and the K-wire that is inserted through a proximal portion of the middle phalanx is passed out a distal end of a distal phalanx (e.g., see at least Applicant’s claim 22 and Austin paragraphs [0064]-[0065]). Absent any unexpected advantage or result, the claim limitation is not novel over the prior art.
Priority
This application appears to disclose and claim one of a substantial portion of prior Application No. 18/053,883, filed November 9, 2022 [and including provisional and prior PCT applications related thereto] or only subject matter disclosed in said prior Application No. 18/053,883, filed November 9, 2022 [and including provisional and prior PCT applications related thereto] and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute either a continuation or divisional or continuation-in-part of the prior application. Should Applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required. Paragraphs [0027]-[0028] of the originally filed disclosure describes a “first” K-wire being inserted into the proximal phalanx and a “second” K-wire being inserted into the middle phalanx, wherein a “first” aperture is located within the middle phalanx and the “second” aperture is located within the proximal phalanx (as required by original claim 1, inter alia, note paragraph [0028] stating “followed” regarding the K-wire being inserted into the middle phalanx). However, amended new claims 21-38 are inconsistent with the original disclosure and original claim 1 by requiring a “first” K-wire to be inserted into a “first” aperture within the middle phalanx, and a “second” K-wire to be inserted into a “second” aperture within the proximal phalanx.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-22, 24-25, 27-30 and 32-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”).
Regarding claim 21, Austin discloses a method of digital arthrodesis or hammertoe correction (e.g., see at least paragraphs [0035], [0063] and [0070], etc.), comprising: accessing a proximal interphalangeal joint between a middle phalanx and a proximal phalanx (e.g., see at least paragraph [0064]); inserting a first K-wire into the middle phalanx (e.g., see at least paragraph [0066]); drilling and/or tapping a first aperture within the middle phalanx and/or resecting bone and/or cartilage from the middle phalanx using one or more instruments inserted over the first K-wire (e.g., see at least paragraph [0066]); inserting a second K-wire into the proximal phalanx (e.g., see at least paragraphs [0064] and [0066]); drilling and/or tapping a second aperture within the proximal phalanx and/or resecting bone and/or cartilage from the proximal phalanx using one or more instruments inserted over the second K-wire (e.g., see at least paragraph [0066]); inserting a proximal portion (602) of a cannulated implant (600-e.g., figure 10; paragraph [0043]) within the second aperture of the proximal phalanx [regardless of ordering for doing such method step, since order for the step to be done before or after any other step is not positively claimed within the claim] (e.g., see at least paragraph [0067]); inserting an end of the first K-wire into a passage of the cannulated implant (100, 200); inserting a distal portion of the cannulated implant within the first aperture of the middle phalanx over the first K-wire [regardless of ordering for doing such method step, since order for the step to be done before or after any other step is not positively claimed within the claim] (paragraphs [0067]-[0069]); and manually compressing the distal portion (104, 604) of the cannulated implant within the middle phalanx [regardless of ordering for doing such method step, since order for the step to be done before or after any other step is not positively claimed within the claim] (e.g., see at least figures; and paragraph [0065]).
Regarding claim 22, Austin discloses the first K-wire is inserted through a proximal portion of the middle phalanx and out past a distal end of a distal phalanx (e.g., see at least paragraphs [0068]- [0069]).
Regarding claim 24, Austin discloses the middle phalanx is distracted distally to advance the distal portion of the cannulated implant (600) into the first aperture of the middle phalanx (e.g., see at least paragraphs [0065] and [0068]).
Regarding claim 25, Austin discloses the method further comprising radiographically (i.e., with fluoroscopic views) checking that the second K-wire is centered on a face and/or at a correct depth within the proximal phalanx (e.g., see at least paragraph [0066]).
Regarding claim 27, Austin discloses the cannulated implant (600) has a transition portion (606) positioned between the proximal portion (602) and the distal portion (604), wherein the transition portion (606) comprises a bend (e.g., see at least figures 6, 9 and 10; and paragraph [0043]).
Regarding claim 28, Austin discloses the cannulated implant (600) includes a threaded portion (threads of 602) positioned along the proximal portion (602) (e.g., see at least paragraph [0043] and figure 6).
Regarding claim 29, Austin discloses the cannulated implant (600) includes a finned portion (fins forming “fixation portion” of 604) positioned along the distal portion (604) (e.g., see at least paragraph [0043] and figure 6), the finned portion configured to prevent migration and/or rotation of the implant in use (e.g., see at least figures 6, 9 and 10).
Regarding claim 30, Austin discloses the threaded portion (threads of 602) comprises a first cross-sectional shape and the finned portion (fins of 604) comprises a second cross-sectional shape (e.g., see at least figures 7 and 8).
Regarding claim 32, Austin discloses the passage (1002) extends linearly from a proximal end of the implant to a distal end of the implant (e.g., see at least figures 7, 8 and 10).
Regarding claim 33, Austin discloses the implant comprises a metallic material (e.g., see at least paragraphs [0011], [0028], [0046], etc.).
Regarding claim 34, Austin discloses the implant comprises a polymeric material (e.g., see at least paragraphs [0011], [0027]-[0028], etc.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”).
Regarding claim 23, as described supra, Austin discloses the method substantially as claimed.
Austin is silent regarding advancing the first K-wire into the middle phalanx and across a metatarsophalangeal joint is done after inserting the proximal portion of the cannulated implant into the second aperture of the proximal phalanx.
However, this limitation is not found persuasive because selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). In the instant case, Applicant has failed to show how or why any new or unexpected results are formed by changing the order of the method steps, namely changing the order from inserting the implant first into the middle phalanx and then into the proximal phalanx to inserting the implant into the proximal phalanx and then into the medial phalanx. In Applicant’s invention, just like that of the prior art, each of the distal and proximal portions of the cannulated implant are compressed into their respective portions of bone, and the K-wire that is inserted through a proximal portion of the middle phalanx is passed out a distal end of a distal phalanx (e.g., see at least Applicant’s claim 22 and Austin paragraphs [0064]-[0065]). Absent any unexpected advantage or result, the claim limitation is not novel over the prior art.
Claims 26 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”) in view of Champagne et al. U.S. publication no. 2019/0070013 A1 (“Champagne”).
Regarding claims 26 and 31, as described supra, Austin discloses the method substantially as claimed. Austin further discloses the first-cross sectional shape (shown in figure 7) comprises a circle (e.g., see at least figure 7). However, Austin is silent regarding the second-cross sectional shape comprises an oval substantially as claimed.
In the same field of endeavor, namely phalange implants, Champagne teaches using a second cross-sectional shape comprising an oval (e.g., see at least paragraph [0025]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to form the second-cross-sectional shape as an oval in order to, among other things, aid in torsional stability with predictable results and a reasonable expectation of success.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”) in view of Barry et al. U.S. publication no. 2017/0348032 A1 (“Barry”).
Regarding claim 35, as described supra, Austin discloses the invention substantially as claimed. Austin is silent regarding the implant comprises an allograft material substantially as claimed. In the same field of endeavor, namely implants for correcting hammertoe and other deformities (e.g., see at least paragraph [0067]), Barry teaches an implant may comprise an allograft material (e.g., see at least paragraphs [0116]-[0117]). Moreover, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Thus, it would have been obvious to one ordinary skill in the art at the time of the effective filing date of the claimed invention to form the implant comprising an allograft material as a known, suitable material selectable as a biocompatible material that may be desired for integration of the implant over time with predictable results and a reasonable expectation of success.
Claims 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”) in view of Dixon et al. U.S. patent no. 6,695,845 B2 (“Dixon”).
Regarding claims 36-38, as described supra, Austin discloses the invention substantially as claimed. Austin is silent regarding the first and second instruments are a one-step drill, tap and reamer substantially as claimed.
In the same field of endeavor, namely bone implants, Dixon teaches an instrument formed as a one-step drill, tap and reamer (e.g., see at least figures 11; and col. 9, lines 5-6).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use an instrument with features as taught and/or suggested by Dixon in the method of Austin in order to minimize the tooling and steps necessary to prepare the bone for implant insertion with predictable results and a reasonable expectation of success.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA LYNN WATKINS whose telephone number is (571)270-1456. The examiner can normally be reached Mon. & Tues. 3-8pm and Thurs. 12-6pm.
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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774